APPLICATION
ANDA091432
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-19
LATEST ACTION
2023-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
NAPROXENPrescription
NAPROXEN 375MG · TABLET, DELAYED RELEASE · ORAL
NAPROXENPrescription
NAPROXEN 500MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-03-08Labeling · Supplement 12 · standardAP
2019-11-25Labeling · Supplement 3 · standardAP
2019-11-25Labeling · Supplement 6 · standardAP
2019-11-25Labeling · Supplement 9 · standardAP
2015-05-04Labeling · Supplement 2 · standardAP
2011-09-19OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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